Clinical trials: Medication Safety
Diabetes Mellitus, Type 2
Gan & Lee Insulin Glargine Target Type (2) Evaluating Research
Primary Objective: To evaluate equivalence of Gan \& Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin…
- Trial name
- GLITTER 2 (NCT03371108)
- Testing
- Gan & Lee Insulin Glargine Injection, Lantus®
- Where
- 57 sites in United States
- Volunteers
- 567 people
- Sponsor
- Gan and Lee Pharmaceuticals, USA
Anemia
Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.
The purpose of this study is to determine the efficacy and safety of peginesatide injection for maintenance treatment of anemia in participants on peritoneal dialysis.
- Trial name
- NCT00752791
- Testing
- Peginesatide
- Where
- 23 sites in United States, Australia and 3 more
- Volunteers
- 59 people
- Sponsor
- Takeda
Healthy Volunteers
Phase 1, TAK-915-1001, Single-Rising Dose, Multiple-Rising Dose, Drug-Drug Interaction, Relative Bioavailability, Food Effect, and Effect on Elderly Participants Study
The purpose of this study is to characterize the safety, tolerability and plasma pharmacokinetic (PK) profile of TAK-915 when administered as single and multiple oral suspension doses at escalating dose levels in healthy…
- Trial name
- NCT02461160
- Testing
- TAK-915 suspension, Midazolam, TAK-915 tablet
- Where
- United States
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Takeda
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Type 2 Diabetes
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker
The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme…
- Trial name
- NCT01137474
- Testing
- Dapagliflozin
- Where
- 329 sites in United States, Canada and 14 more
- Volunteers
- 2,996 people
- Sponsor
- AstraZeneca
Central Precocious Puberty
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
The main aim is to see how leuprolide works to treat central precocious puberty in children. Participants will receive an injection of leuprorelin acetate depot 11.25 mg every 12 weeks during 6 months and will visit their study…
- Trial name
- PUPIL (NCT05341115)
- Testing
- Leuprorelin Acetate Depot 3M
- Where
- 5 sites in China
- Volunteers
- 79 people
- Sponsor
- Takeda
Cachexia, Non-Small-Cell Lung Cancer
Study to Assess the Safety and Tolerability of Repeated Doses of an Investigational New Drug in Patients With Cancer and Cachexia.
Study to assess the safety and tolerability of repeated doses of an investigational new drug in patients with cancer and cachexia.
- Conditions
- Cachexia, Non-Small-Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- Trial name
- NCT04299048
- Testing
- PF-06946860
- Where
- 10 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.
- Trial name
- TULIP (NCT03262935)
- Testing
- (vic-)trastuzumab duocarmazine, Physician's choice
- Where
- 90 sites in United States, Belgium and 9 more
- Volunteers
- 437 people
- Sponsor
- Byondis B.V.
Crohn's Disease
Efficacy and Safety of Vedolizumab Subcutaneous (SC) as Maintenance Therapy in Crohn's Disease (CD)
The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration…
- Trial name
- NCT02611817
- Testing
- Vedolizumab SC 108 mg, Vedolizumab IV 300 mg
- Where
- 194 sites in United States, Australia and 28 more
- Volunteers
- 644 people
- Sponsor
- Takeda
Rheumatoid Arthritis (RA)
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function.
- Trial name
- NCT04888585
- Testing
- ABBV-154
- Where
- 220 sites in United States, Australia and 19 more
- Volunteers
- 473 people
- Sponsor
- AbbVie
Asthma
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp…
- Trial name
- NCT01576718
- Testing
- Fp MDPI, Flovent Diskus, albuterol/salbutamol
- Where
- 300 sites in United States, Australia and 17 more
- Volunteers
- 889 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Coronary Artery Disease
Safety and Effectiveness of Agent Paclitaxel-Coated PTCA Balloon Catheter. (AGENT Japan SV)
A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.
- Trial name
- NCT04058990
- Testing
- Device: Paclitaxel-Coated PTCA Balloon Catheter, SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel
- Where
- 14 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Boston Scientific Corporation
Atrial Fibrillation
SMART-SF Radiofrequency Ablation Safety Study
This is a prospective safety assessment of the study device during radiofrequency (RF) ablation treatment of patients with drug refractory symptomatic atrial fibrillation (SMART-SF).
- Trial name
- NCT02359890
- Testing
- THERMOCOOL® SMARTTOUCH® (RF ablation treatment)
- Volunteers
- 165 people
- Sponsor
- Biosense Webster, Inc.
Pain, Cancer
Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.
- Trial name
- NCT00675948
- Testing
- Sativex, GW-2000-02
- Where
- United Kingdom
- Volunteers
- 43 people
- Sponsor
- Jazz Pharmaceuticals
Type 2 Diabetes
Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes
The purpose of this study is to try and achieve similar glycemic control in general non-Intensive Care Unit (non-ICU) patients with Type 2 Diabetes with exenatide alone or in combination with basal insulin as compared to…
- Trial name
- NCT02455076
- Testing
- Exenatide, Glargine, Rapid-acting insulin analogs
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Emory University
Paroxysmal Atrial Fibrillation
TactiSense IDE Trial of TactiCath SE for Paroxysmal Atrial Fibrillation
This clinical investigation is intended to demonstrate the acute safety and effectiveness of ablation with the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for the treatment of drug refractory…
- Trial name
- TactiSense (NCT03354663)
- Testing
- TactiCath SE
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 156 people
- Sponsor
- Abbott Medical Devices
Interstitial Lung Disease, Diffuse Parenchymal Lung Disease
Hydroxychloroquine (HCQ) in Pediatric Interstitial Lung Disease (ILD)
This is an exploratory Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multinational study investigating the initiation or withdrawal of hydroxychloroquine in subjects with chILD.
- Conditions
- Interstitial Lung Disease, Diffuse Parenchymal Lung Disease, Children´s Interstitial Lung Disease
- Trial name
- HCQ-chILD-EU (NCT02615938)
- Testing
- Hydroxychloroquine sulfate
- Where
- 9 sites in Germany
- Volunteers
- 35 people
- Sponsor
- Matthias Griese
HIV-1 Infection
A Study to Evaluate the Pharmacokinetic Profile (How the Body Absorbs, Distributes, Metabolizes and Eliminates a Drug) of TMC125 Plus Tenofovir/Emtricitabine Once Daily With or Without Darunavir/r Once Daily in Antiretroviral (ARV) Naive HIV-1 Patients (Patients Have Never Received ARV Treatment).
The purpose of this study is to determine the pharmacokinetic profile of TMC125 400mg with tenofovir DF/emtricitabine FDC (fixed dose combination) 300/200mg all dosed once daily with and without darunavir/ritonavir 800/100 mg…
- Trial name
- NCT00534352
- Testing
- TMC125; darunavir; ritonavir
- Volunteers
- 23 people
- Sponsor
- Tibotec, Inc
Limbal Stem Cell Deficiency
Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft
The main aim of the study is to determine the safety and feasibility of a cultivated autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem cell deficiency.
- Trial name
- CALEC (NCT02592330)
- Testing
- Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft, Cultivation of Limbal epithelial cells into a graft, CALEC Transplant
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Massachusetts Eye and Ear Infirmary
Medication Adherence
Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence
In pharmacotherapy trials involving drug-dependent individuals, medication compliance is a significant issue, as rates tend to be low and adherence to medication may predict improved outcomes (Baros et al, 2007; McRae et al…
- Trial name
- NCT02344251
- Testing
- MEMS Cap, ID-Cap
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
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